What You Need to Know:

Results of a phase 1 study demonstrated that vaccination against influenza using a dissolvable microneedle patch is not only well tolerated, but also produces “robust antibody responses.”

Trial Design:

Placebo-controlled phase 1 study assessed the safety, immunogenicity, and tolerability of dissolvable microneedle patches for delivery of the influenza vaccine

100 patients were randomized “(1:1:1:1) to four groups and received a single dose of inactivated influenza vaccine (fluvirin: 18 μg of haemagglutinin per H1N1 vaccine strain, 17 μg of haemagglutinin per H3N2 vaccine strain, and 15 μg of haemagglutinin per B vaccine strain) (1) by microneedle patch or (2) by intramuscular injection, or received (3) placebo by microneedle patch, all administered by an unmasked health-care worker; or received a single dose of (4) inactivated influenza vaccine by microneedle patch self-administered by study participants”

Partly blinded study: patients were not masked to vaccine route of administration

Primary safety endpoints: occurrence of serious adverse events within 180 days of product administration, grade 3 adverse events (solicited or unsolicited) that occurred within 28 days of administration, reactogenicity (systemic and injection site) at product administration through day 7

Geometric mean titers reported for patients who self-administered the microneedle patch were also similar (P>0.05)

Seroconversion percentages: significantly higher in patients who received the microneedle patch vaccination vs patients who received placebo (P<0.0001) and similar to patients who received vaccination via intramuscular injection (P>0.01)